FDA UDI
In Commercial Distribution
🇺🇸 United States
EV1000
DI: 00690103190113
·
Model: EV1000DB
·
Edwards Lifesciences LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EV1000
- Primary DI
- 00690103190113
- Version / Model
- EV1000DB
- Catalog Number
- EV1000DB
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-03
- Public Version
- 6
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 7dde6139-5334-4271-8473-8f21fdaacc46
Device Description
EV1000 DATABOX ASSEMBLY
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION | Cardiovascular | 870.1435 | 2 |
| DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Cardiovascular | 870.1130 | 2 |
| DSB | PLETHYSMOGRAPH, IMPEDANCE | Cardiovascular | 870.2770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33586 | General-purpose multi-parameter bedside monitor | An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00690103190113 | GS1 |
Customer Contacts
- Phone
- +1(800)822-9637
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Height: 145 mm, Width: 206 mm, Depth: 64 mm, Weight: 0.9 kg (2.0 lbs) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE IN A COOL, DRY PLACE.